Providing thoughtful, experienced leadership in biopharmaceutical regulatory affairs...

More than 35 years of experience in regulatory management and development of biotechnology-derived pharmaceutical products
Initiated, developed, and directed the Regulatory Affairs function at Amgen Inc., a world-class biotechnology pioneer. Defined and implemented regulatory strategies for Amgen's first five therapeutic products, leading to marketing approval of the company's first multi-billion-dollar product. Provided consultative services to the company for 16 years.
Provided consultative services to more than 35 companies of all sizes, at all stages of product development, and in locations including the U.S., Japan, Europe, Canada, and Australia.
Extensive experience in the regulatory management of development programs for both biological pharmaceuticals and drug products, from management of pre-IND regulatory interactions to submission and management of marketing ap-plications. Additional experience in the development of animal products, diagnostics, and monoclonal antibody products in the U.S.
Experienced in the management of "virtual" companies which rely heavily upon the services of external contract organizations, in place of more traditional organizational infrastructure.
Expertise in regulatory issues surrounding all phases of product development: pre-clinical research and development; GLP, GMP, and GCP compliance; clinical investigations; scale-up and manufacturing; and strategic positioning.